Natural Disease Progress of Dupuytren Disease

NCT01923103 | Completed

• 1 other identifier: NDPDD
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown. The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.

Conditions

Dupuytren Contracture; Disease Progression

Outcome Measures

Primary Outcomes (1)

• The course of DD: passive and active extension deficit and dimension of palpable nodules and cords

  Active and passive extension deficit is measured with a goniometer at joint level Dimension of nodules and cords is measured using a tumorimeter

  every 6-12 months

Secondary Outcomes (2)

• Disease activity: Echogenicity and nodule hardness

  every 12 months, starting from 2016 (ultrasound) and 2018 (tonometry)

• Patient-reported hand function: MHQ, PRWHE and URAM

  every 6-12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Dupuytren Disease who participated in prior studies and patients from the outpatient clinic

You may qualify if:

• Patients (\> 18 years of age) with primary Dupuytren's disease in all Tubiana stages
• Operated hands of patients with primary Dupuytren's disease on the contra lateral hand

You may not qualify if:

• Patients who are incapable of giving consent
• Patients who are not able or not willing to visit the UMCG for follow-up
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Dupuytren Contracture; Disease Progression

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul MN Werker, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 14, 2013
• Study Start: June 22, 2012
• Primary Completion: March 1, 2023
• Study Completion: March 20, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)